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Approval and Regulation of Antibiotics Used in Animals

The FDA assesses safety and risk of animal antibiotics

The FDA is responsible for the approval of both human and animal drugs, and it enforces comparable standards for safety, efficacy and quality and uses similar procedures during the review and approval process. All drugs must demonstrate they are safe and effective for the labeled indication(s), must be properly labeled, and must be produced under good manufacturing practices.

However, the safety assessment for antibiotics for food animals is more expansive than that for human antibiotics. Specifically, for animal antibiotics, the FDA requires animal medicine companies to conduct risk assessments to ensure that the antibiotic will not present a significant risk to human health from exposure to antibiotic resistant bacteria in meat and poultry products. Companies must also conduct studies to determine a safe level of any residues that may remain in the animal after treatment with the antibiotic. Based on that safe level, the FDA establishes a drug withdrawal time that must be followed before the animal can be processed for food or milk.

FDA Approval Process

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Labeling of
Animal Antibiotics